The installations, the equipment, and the operational procedures relevant to the process of sterilization, moulding and extrusion are worked out and defined according to the most up-to-date international guidelines (Normative EN-ISO, G.M.P., F.U.I., AINSI/HIMA).
In the CLEAN ROOM (class 8 according to ISO 14644 – 1:), all the productions and control operations are carried out making sure that those conditions are kept as such, by performing regular microbial and particles control checks.
The environmental parameters are constantly and strictly maintained by using filtering, air conditioning and pressurisation equipment in line with the F.U.I. requirements and relative updates.
The microbiological contamination of the products is kept under control by carrying out regular ‘bioburden’ tests.
THE QUALITY CONTROL is performed according to International Normative, which expects verifications at each stage of the production. Each production batch is subject to a constant, technical, chemical and biological control, starting from the initial use of the raw materials to the sterilisation process.